Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients

Completed

• Conditions: Parkinson Disease; COVID
• Interventions: Other: Questionnaire and interview

• Registration Number: NCT04466839
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

The consequences of COVID-19 in these already fragile patients should be evaluated. It will be important to appreciate the confinement consequences imposed on the patient on the course and impact of the disease.

These consequences can be assessed by the end of confinement and 6 months after the latter is lifted.

Detailed Description

Adaptation capacities are necessary to cope with the brutal and drastic changes imposed by the pandemic and its consequences. In Parkinson's disease, where there are routine situations with difficulties adjusting to newness, patients in the current situation may be particularly affected and present anxiety due to great difficulties in adaptation.

The repercussions in terms of symptoms (motor and non-motor) of the disease could be very significant. In this population already widely exposed to anxio-depressive symptoms (depression being a common symptom of Parkinson's disease, affecting up to 30 to 40% of patients outside of crisis periods), we can expect a risk increased psychiatric decompensation. The psychiatric consequences could not be limited to the current period but also concern long-term patients, in particular if there is decompensation of other symptoms of the disease (motors, complications linked to treatment, etc.).

The consequences of COVID-19 in these already fragile patients should be evaluated. It will be important to appreciate the confinement consequences imposed on the patient on the course and impact of the disease.

These consequences can be assessed by the end of confinement and 6 months after the latter is lifted.

This is an observational, French multicenter study, of an uncontrolled cohort of parkinsonian patients followed by doctors from Parkinson Expert Centers in hospitals.

Study Timeline

• Study First Submitted: 2020-06-23
• Study Start: 2020-07-02
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-10
• Primary Completion: 2020-12-18
• Study Completion: 2020-12-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

Inclusion Criteria

• Patient followed by a doctor from the Parkinson Expert Center of the Toulouse University Hospital, Lille, Paris, Rouen, Nimes, Reims, Besancon, Marseille
• And with idiopathic Parkinson's disease
• Patients hospitalized or in consultation between 16/03/2020 and 16/05/2020.

Exclusion Criteria

• Atypical parkinsonian syndrome
• Patient subject to a legal protection order (tutorship)
• Patient not wishing to answer questions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
parkinsonian patients	Questionnaire and interview	Cohort of parkinsonian patients followed by doctors from the Parkinson Expert Centers in teaching hospitals.

Primary Outcome Measures

Name	Time	Method
Impact of containment related to the Covid-19 pandemic.	6 months after the end of the pandemic	To compare quality of life using Parkinson Disease Questionnaire-8 Items (PDQ-8 ), during the period of confinement linked to the Covid-19 pandemic and 6 months after the end of the pandemic in patients with idiopathic Parkinson's disease.; The minimum value is "never" and maximum value is "always"

Secondary Outcome Measures

Name	Time	Method
The number of patients infected or possibly infected with Covid-19	6 months after the end of the pandemic	Infected patients will be defined as having had a positive polymerase chain reaction (PCR) or compatible chest scanner. Patients potentially infected: patients who presented symptoms during the period which could suggest an infection by the Covid-19 virus: cough, fever and dyspnea
Symptoms modifications	6 months after the end of the pandemic	Patients will be asked to list the 3 main symptoms that have changed during the confinement period
Conditions of containment during the Covid-19 pandemic.	Day 1	Describe in a cohort of Parkinson's patients the conditions of confinement during the confinement period linked to the Covid-19 pandemic such as lifestyle (patient living alone, patient living with a caregiver, patient living in nursing home) and continuing paramedical care (physiotherapist, speech therapist), thanks to a psychosocial assessment

Trial Locations

Locations (8)

Centre Hospitalier Régionale Universitaire de Besançon; 🇫🇷 Besançon, France

Centre Hospitalier Universitaire de Reims; 🇫🇷 Reims, France

Centre Hospitalier Universitaire Lille; 🇫🇷 Lille, France

Centre Hospitalier Universitaire de la Pitié-Salpêtrière; 🇫🇷 Paris, France

Centre Hospitalier Universitaire de Marseille; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Nîmes - Caremeau; 🇫🇷 Nimes, France

Centre Hospitalier Universitaire de Rouen; 🇫🇷 Rouen, France

CHU Toulouse; 🇫🇷 Toulouse, France